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. 2017 May 10;2017(5):CD006185. doi: 10.1002/14651858.CD006185.pub4

Han 2016.

Methods RCT
 Method of randomisation: not stated
 Blinding of outcome assessors: stated as 'yes'
 Adverse events: none
 Deaths: none
 Dropouts: 4 in control group (2 refused and 2 dropped)
ITT: no
Participants Country: Republic of Korea
60 participants (30 in treatment group, 30 in control group)
 Non‐ambulatory at start of study
 Mean age: 68 years in experimental group and 63 years in control group
Inclusion criteria: clinical diagnosis of stroke < 3 months after stroke onset, first‐ever stroke, dependent ambulation with severe gait impairment (FAC < 2), and sufficient cognition to understand procedures and provide informed consent
Exclusion criteria: contraindications for RAGT therapy; cerebellar or brainstem lesions that could affect autonomic or balance function; musculoskeletal disease involving the lower limbs, such as severe painful arthritis, osteoporosis, amputation, or joint contracture; and other concurrent neurological diseases (e.g. Parkinson's disease, multiple sclerosis, etc.)
Interventions 2 arms:
  • Experimental group: 30 minutes of exoskeletal robot‐driven gait orthosis training (Lokomat) and 30 minutes conventional rehabilitation therapy 5 times per week for 4 weeks

  • Control group: 60 minutes conventional rehabilitation therapy. Physical therapy conducted by physical therapists certified in neurodevelopmental techniques was provided for balance and mobility 5 times per week for 4 weeks

Outcomes Outcomes were recorded at baseline and after the 4‐week intervention; all outcome parameters were measured within 3 days before and after 20 sessions of training:
  • Primary outcomes: brachial–ankle pulse wave velocity (baPWV, which evaluates arterial stiffness) and cardiopulmonary fitness

  • Secondary outcomes: clinical functional outcomes, including basic ADL function, balance, gait functions, and motor functions of the paretic lower limb

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation not described.
Allocation concealment (selection bias) Unclear risk Allocation concealment not described.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk A physiatrist (rehabilitation doctor) who remained blinded to participant group and treatment throughout the entire study analysed outcome measures.
Incomplete outcome data (attrition bias) 
 All outcomes High risk No ITT